Recall Z-1432-2025 — Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.
U.S. FDA — Device Enforcement · United States · 2025-02-20 · Class II
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Reported risk: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
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